Early A1C test may reduce gestational diabetes risk: NIH study

The NIH researchers analyzed records from the NICHD Fetal Growth Study of more than 2,000 low-risk pregnant women from 12 U.S. clinical sites between 2009 and 2013.

By Susan Kelly • Aug. 17, 2018

DeepMind's AI detects over 50 eye diseases with 94% accuracy, study shows

The work is a collaboration between Google's DeepMind subsidiary, Moorfields Eye Hospital and University College London to speed diagnosis and referrals for sight-threatening eye diseases.

By Meg Bryant • Aug. 15, 2018

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

AdvaMed pushes back against FDA humanitarian device guidance

The trade group thinks the guidance will deter development of devices to treat rare conditions.

By Nick Paul Taylor • Aug. 15, 2018

Medical device industry caught in US-China trade war

"If this keeps escalating … a tit-for-tat game without any end in sight, that's very concerning to our industry and ultimately to patient care," a top industry imaging official said.

By Meg Bryant • Aug. 13, 2018

FDA warns overreliance on membrane tests could up fetal death risk

The rupture test results could be misinterpreted, leading to serious adverse events.

By Nick Paul Taylor • Aug. 9, 2018

Boston Children's expands sequencing of patients with epilepsy, IBD

The hospital hopes to learn more about disease pathways and identify novel drug targets.

By Nick Paul Taylor • Aug. 8, 2018

New blood test can rule out heart attack faster

The new test showed greater sensitivity and precision than the fourth-generation conventional test currently in use in the United States.

By Susan Kelly • Aug. 7, 2018

UK regulators reassure medtech sector about Brexit impact

The MHRA expects little to change until 2021 but the risk of significant near-term upheaval remains.

By Nick Paul Taylor • Aug. 7, 2018

Industry urges Congress to ease clinical lab pay cuts

The medical device and hospital industries are among those arguing that under the first six months of new reimbursement rates, labs have cut staff, resulting in limited or ended home care visits for homebound patients.

By David Lim • Aug. 3, 2018

Bio-Techne closes $250M Exosome Diagnostics takeover

The acquisition moves the company into the nascent liquid biopsy sector.

By Nick Paul Taylor • Aug. 3, 2018

Siemens Healthineers hits Q3 goals as imaging sales rise

Demand for molecular imaging, X-ray products and magnetic resonance drove growth.

By Nick Paul Taylor • Aug. 2, 2018

MedTech Europe seeks 'urgent' changes to EU regs deadlines

The trade group proposes either stopping the clock on the countdown to the end of the transition periods or delaying the implementation dates for all products, or just legacy products. 

By Nick Paul Taylor • July 31, 2018

ECRI safety panel advises 3 ways to avoid diagnostic testing, medicine mix-ups

"The problem of not closing the loop has a significant impact on patients and caregivers, and can lead to devastating effects on the outcome of patients, workgroup chair Chris Lehmann said.

By David Lim • July 27, 2018

IBM's Watson gave 'unsafe and incorrect' cancer treatment advice: STAT report

No patients died as a result of inaccurate recommendations, according to internal documents obtained by the news organization.

By Meg Bryant • July 26, 2018

GSK teams up with 23andMe to boost R&D

As part of a broader restructuring, the British pharma hopes to tap 23andMe's genetic database to develop better drugs and more easily find patients.

By Lisa LaMotta • July 25, 2018

LabCorp lowers 2018 diagnostics arm growth guidance

The unit saw a drop in adjusted operating income, attributed to the negative impact from the Protecting Access to Medicare Act.

By David Lim • July 25, 2018

Quest Diagnostics posts slight Q2 revenue miss

CEO Stephen Rusckowski said the company welcomes CMS' recent proposal to change how it collects clinical laboratory fee data.

By Susan Kelly • July 24, 2018

5 key parts of the FDA Medical Device Safety Action Plan

The ambitious proposal focuses on a total lifecycle approach to device safety.

By Meg Bryant • July 23, 2018

LabCorp shuts down IT system after possible hack attack

The company's response delayed the transmission of test results to customers.

By Nick Paul Taylor • July 19, 2018

Abbott beats expectations as sales of diabetes device soar

Glucose monitor FreeStyle Libre drove 40% growth at the diabetes unit, the company's best performer.

By Nick Paul Taylor • July 19, 2018

CMS targets data gaps in setting lab payments

The American Clinical Laboratory Association said it "will urge Congress as well as CMS to address significant shortfalls in the data collection process that jeopardize care for the most vulnerable seniors."

By Susan Kelly • July 16, 2018

Transition clock ticking on new EU device regs

"It's a problem because how do you comply with a new standard when you don't know what the standard is?" said AdvaMed's Joe Gatewood.

By Meg Bryant • July 16, 2018

Feds pump $24M into development of at-home flu tests

Cue Health and Diassess will split the funding. The government thinks the diagnostics could curb the spread of pandemic viruses.

By Nick Paul Taylor • July 12, 2018

Wearable ECG patch increases atrial fibrillation diagnosis in clinical trial

Use of a digital health device has increased diagnosis of atrial fibrillation, raising hopes that stroke risk can be reduced.

By Nick Paul Taylor • July 11, 2018

Data-sharing site seeks to battle underground chemists in opioid fight

US agencies are teaming with the German government to help forensic chemists share data on new drug variants.

By Susan Kelly • July 9, 2018